deramiocel

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News(10)

• STAT+: Capricor Therapeutics’ Duchenne treatment is heading for an FDA rejection
  Capricor Therapeutics is trying to stave off FDA rejection of its cell therapy for Duchenne muscular dystrophy.
  stat · 16h ago
• Opinion: Capricor’s Duchenne muscular dystrophy drug and the countless tiny decisions that can make or break a study
  “Regulatory flexibility can be exercised in rare disease without sacrificing rigor,” writes Mindy Leffler, whose son has Duchenne muscular dystrophy.
  stat · 18h ago
• Capricor soars on potential FDA review extension, filing amendments
  Capricor Therapeutics’ CEO Linda Marbán believes the FDA is willing to work with the biotech as the Aug. 22 deadline approaches for its Duchenne muscular dystrophy cell therapy deramiocel, with the…
  biospace · 6d ago
• Capricor shares spike on CEO comments; Cytokinetics sues Bristol Myers
  The FDA is “willing to review” an updated submission for Capricor’s Duchenne cell therapy, its CEO said. Elsewhere, a heart drug battle spilled into court and Rigel priced the first “Protac” medicine.
  biopharma_dive · 6d ago
• Capricor soars on plan to amend DMD filing after adcomm setback
  Capricor Therapeutics has bounced back from a bruising FDA advisory committee meeting by securing a green light to file an amendment to its approval application, raising hopes that the biotech can…
  fiercebiotech · 6d ago
• Third time’s the charm for Replimune as melanoma drug earns FDA greenlight
  Replimune’s immunotherapy for advanced melanoma faced a perilous regulatory road with two previous rejections, but the drug—to be marketed as Tudriqev—prevailed with strong support from oncologists…
  biospace · 14d ago
• Chaotic adcomms threaten to derail FDA’s bid to renew trust after Makary, Prasad
  The FDA has been trying to mend fences with rare disease drug developers and patient groups since the departure of former Commissioner Marty Makary three months ago. But advisory committee meetings…
  biospace · 15d ago
• Rumors of biggest pharma merger ever drop amid Q2 earnings, contentious FDA adcomms
  The industry has been abuzz since the weekend when talks of a potential mega-merger between Bristol Myers Squibb and AstraZeneca were reported. Meanwhile, Pfizer, Merck and others release second qu…
  biospace · 15d ago
• Capricor CEO won’t rule out legal action against FDA after negative adcomm
  After an FDA advisory committee voted 9-3 on Wednesday against recommending Capricor Therapeutics’ Duchenne muscular dystrophy cardiomyopathy drug for approval, stakeholders allege an “ulterior mot…
  biospace · 20d ago
• UniQure welcomes possible adcomm for Huntington’s asset as regulatory ‘jitters’ spread through biopharma
  UniQure is ready to put its Huntington’s disease gene therapy through an advisory committee meeting—even as the broader rare disease space has been put on edge by recent FDA scrutiny of assets by R…
  biospace · 20d ago